Associate Director, GMP Quality Assurance
Structure Therapeutics
15 days ago
Remote friendly (South San Francisco, CA)
United States
Operations
Position Summary
Reporting to the Director of Quality Assurance, responsible for strategic and operational quality oversight of late-phase drug substance (DS) manufacturing and testing activities at CDMOs; primary QA point of contact for DS vendors to ensure GMP compliance, regulatory readiness, and successful clinical/commercial supply.
Job Responsibilities
- Serve as QA lead for drug substance CDMO oversight; ensure GMP compliance across manufacturing, testing, and release.
- Provide real-time QA support/decision-making for DS manufacturing campaigns (batch disposition, deviations, lab investigations, change control).
- Review and approve key GMP documents (master batch records, executed batch records, protocols, reports, specifications).
- Ensure timely resolution of deviations, investigations, CAPAs, and change controls.
- Interface with CDMOs while maintaining appropriate quality oversight.
- Participate in vendor selection/qualification/performance management (audits, quality agreements).
- Partner with Analytical Development, QC, Manufacturing/CMC, Regulatory Affairs, and Supply Chain to align DS quality/compliance strategies.
- Support regulatory inspections/filings with inspection-ready DS documentation.
- Contribute to development/implementation/continuous improvement of external manufacturing quality systems.
- Mentor QA staff; help build a high-performing QA organization.
- Support DS-related risk management (quality and supply).
- Participate in internal audits and health authority inspections as DS quality SME.
- Provide early-phase QA support as needed.
- Stay current with evolving GMP/ICH and external manufacturing oversight requirements/trends.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
- 10+ years pharma/biotech experience with significant Quality Assurance experience.
- Strong GMP expertise (FDA/EMA/ICH) with late-phase/commercial DS manufacturing experience.
- Experience overseeing CDMOs/external manufacturing networks.
- Knowledge of small molecule DS manufacturing/testing.
- Experience with batch disposition, deviation/lab investigations, change control, CAPA, and risk management.
- Experience supporting regulatory submissions (IND/NDA/MAA) and health authority inspections.
- Strong cross-functional collaboration; influence without authority.
- Excellent communication, problem-solving, and organization.
- Leadership and mentoring capabilities.
- Ability to manage multiple priorities in a fast-paced environment.
Travel Required
- Up to ~20–30% travel.
Benefits (explicitly stated)
- Base pay range: $186,000–$225,000; annual performance incentive bonus; new hire equity; performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays including winter shutdown.
Application Instructions
- Apply via the official career page at BambooHR.
Reporting to the Director of Quality Assurance, responsible for strategic and operational quality oversight of late-phase drug substance (DS) manufacturing and testing activities at CDMOs; primary QA point of contact for DS vendors to ensure GMP compliance, regulatory readiness, and successful clinical/commercial supply.
Job Responsibilities
- Serve as QA lead for drug substance CDMO oversight; ensure GMP compliance across manufacturing, testing, and release.
- Provide real-time QA support/decision-making for DS manufacturing campaigns (batch disposition, deviations, lab investigations, change control).
- Review and approve key GMP documents (master batch records, executed batch records, protocols, reports, specifications).
- Ensure timely resolution of deviations, investigations, CAPAs, and change controls.
- Interface with CDMOs while maintaining appropriate quality oversight.
- Participate in vendor selection/qualification/performance management (audits, quality agreements).
- Partner with Analytical Development, QC, Manufacturing/CMC, Regulatory Affairs, and Supply Chain to align DS quality/compliance strategies.
- Support regulatory inspections/filings with inspection-ready DS documentation.
- Contribute to development/implementation/continuous improvement of external manufacturing quality systems.
- Mentor QA staff; help build a high-performing QA organization.
- Support DS-related risk management (quality and supply).
- Participate in internal audits and health authority inspections as DS quality SME.
- Provide early-phase QA support as needed.
- Stay current with evolving GMP/ICH and external manufacturing oversight requirements/trends.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
- 10+ years pharma/biotech experience with significant Quality Assurance experience.
- Strong GMP expertise (FDA/EMA/ICH) with late-phase/commercial DS manufacturing experience.
- Experience overseeing CDMOs/external manufacturing networks.
- Knowledge of small molecule DS manufacturing/testing.
- Experience with batch disposition, deviation/lab investigations, change control, CAPA, and risk management.
- Experience supporting regulatory submissions (IND/NDA/MAA) and health authority inspections.
- Strong cross-functional collaboration; influence without authority.
- Excellent communication, problem-solving, and organization.
- Leadership and mentoring capabilities.
- Ability to manage multiple priorities in a fast-paced environment.
Travel Required
- Up to ~20–30% travel.
Benefits (explicitly stated)
- Base pay range: $186,000–$225,000; annual performance incentive bonus; new hire equity; performance-based equity; medical/dental/vision; 401k match; unlimited PTO; paid holidays including winter shutdown.
Application Instructions
- Apply via the official career page at BambooHR.